DCLK1 as a Marker/Indicator of Stem Cell Response in Barrett's Esophagus/Esophageal Adenocarcinoma

NCT03526328 | Completed DMC

• 1 other identifier: 1885
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

The hypotheses are: 1) the intestinal stem cell marker, DCLK1, which is increased in both the epithelium and stroma in colon cancer is also increased in BE (Barrett's esophagus) with HGD (high grade dysplasia) and in EAC (esophageal adenocarcinoma), 2) this expression correlates with disease progression towards EAC and 3) eradication of cells expressing stem cell markers occurs after therapy of EMR (endoscopic mucosal resection) or RFA (radiofrequency ablation) to eradicate BE with HGD and intramucosal adenocarcinoma and esophagectomy for EAC. We will test our hypotheses with the following aims: 1) To characterize the cell specific expression patterns of intestinal stem cell biomarkers in BE patients and correlate them with serum expression and disease progression, 2) To examine prospectively the effects of EMR, RFA or esophagectomy on the expression of stem cell biomarkers and the progression to EAC.

Conditions

Barrett's Esophagus; Esophageal Adenocarcinoma

Keywords

DCLK1; Serum Biomarker; Barrett's Esophagus; Esophageal Adenocarcinoma; Tumor Stem Cell Marker

Outcome Measures

Primary Outcomes (1)

• cell-specific expression patterns of putative intestinal stem cell biomarkers in BE patients; correlation of markers with serum/plasma protein expression and disease progression.

  Exploratory; analysis of expression of various markers for Barrett's esophagus and esophogeal adenocarcinoma

  2 yrs

Study Arms (1)

DCLK1 post BE treatment

Effects of EMR and RFA on the expression of putative stem cell biomarkers and correlate them with serum/plasma protein expression and disease progression and/or recurrence (Barrett's esophagus/ esophageal adenocarcinoma)

Other: EMR and RFA effect on stem cell marker expression in BE/EAC

Interventions

EMR and RFA effect on stem cell marker expression in BE/EAC OTHER

Observation of EMR and RFA on the expression of putative stem cell biomarkers and correlate them with serum/plasma protein expression and disease progression and/or recurrence (Barrett's esophagus/ esophageal adenocarcinoma)

DCLK1 post BE treatment

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients presenting for upper endoscopy to evaluate symptoms or risk factors such as GERD, dyspepsia, or dysphagia with a finding of BE or EAC; treatment with EMR or RFA for BE with HGD, focal intramucosal adenocarcinoma or esophagectomy for EAC.

You may qualify if:

• BE length of 12 cm or less
• presence of non-dysplastic BE on 2 sequential endoscopies or low-grade intraepithelial dysplasia (LGIN), high-grade intraepithelial dysplasia (HGIN) or EAC in BE segment on 2 endoscopies in the previous 6 months
• no signs of metastasis on endoscopic ultrasonography or computerized tomography scan.

You may not qualify if:

• pre-RFA EMR with cancer at the resection margin
• greater than T1sm1 invasion
• poor differentiation or worse
• angiolymphatic invasion
• esophageal stenosis preventing passage of an 11.3 mm endoscope
• persistent visible lesions after EMR before RFA and invasive cancer on biopsies after EMR pre-RFA.

Sponsors & Collaborators

• University of Oklahoma: lead

Study Sites (1)

Gastroenterology

Oklahoma City, Oklahoma, 73104, United States

Location

Related Publications (1)

• Vega KJ, May R, Sureban SM, Lightfoot SA, Qu D, Reed A, Weygant N, Ramanujam R, Souza R, Madhoun M, Whorton J, Anant S, Meltzer SJ, Houchen CW. Identification of the putative intestinal stem cell marker doublecortin and CaM kinase-like-1 in Barrett's esophagus and esophageal adenocarcinoma. J Gastroenterol Hepatol. 2012 Apr;27(4):773-80. doi: 10.1111/j.1440-1746.2011.06928.x.

  PMID: 21916995 BACKGROUND

MeSH Terms

Conditions

Barrett Esophagus; Adenocarcinoma Of Esophagus

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Ahmed Bolkhir, MD

  University of Oklahoma

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2013
• First Posted: May 16, 2018
• Study Start: March 1, 2013
• Primary Completion: August 13, 2019
• Study Completion: August 13, 2019
• Last Updated: March 6, 2020

Record last verified: 2020-03

Locations

US (1)